Percutaneous repair of mitral prolapse

ABSTRACT

A mitral valve leaflet repair system may include a delivery catheter having at least one lumen extending proximally from a distal end of the delivery catheter, a plurality of anchor elements disposed within the at least one lumen, each of the plurality of anchor elements being configured to extend through one layer of mitral valve leaflet tissue, and a securing element configured to secure at least two of the plurality of anchor elements together on one side of the mitral valve leaflet tissue. The at least one lumen may include a suction lumen configured to grasp a mitral valve leaflet prior to extending the plurality of anchor elements through one layer of mitral valve leaflet tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119 toU.S. Provisional Application Ser. No. 62/560,508, filed Sep. 19, 2017,the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices and methods for usingmedical devices. More particularly, the present disclosure pertains toaspects of medical devices and/or means to deliver and release medicaldevices for percutaneously treating degenerative mitral regurgitation byisolating redundant tissue in mitral valve leaflets.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, surgical and/or intravascular use. Some ofthese devices include guidewires, catheters, medical device deliverysystems (e.g., for stents, grafts, replacement valves, occlusive medicaldevices, etc.), and the like. These devices are manufactured by any oneof a variety of different manufacturing methods and may be usedaccording to any one of a variety of methods. There is an ongoing needto provide alternative medical devices as well as alternative methodsfor manufacturing and/or using medical devices.

SUMMARY

In a first aspect, a mitral valve leaflet repair system may comprise adelivery catheter having at least one lumen extending proximally from adistal end of the delivery catheter; a plurality of anchor elementsdisposed within the at least one lumen, each of the plurality of anchorelements being configured to extend through one layer of mitral valveleaflet tissue; and a securing element configured to secure at least twoof the plurality of anchor elements together on one side of the mitralvalve leaflet tissue. The at least one lumen may comprise a suctionlumen configured to grasp a mitral valve leaflet prior to extending theplurality of anchor elements through one layer of mitral valve leaflettissue.

In addition or alternatively, and in a second aspect, the at least onelumen further comprises a plurality of anchor lumens, wherein at leastone of the plurality of anchor elements is disposed within each of twoor more of the plurality of anchor lumens.

In addition or alternatively, and in a third aspect, at least one of theplurality of anchor elements is disposed within the suction lumen.

In addition or alternatively, and in a fourth aspect, at least one ofthe plurality of anchor elements comprises a rivet.

In addition or alternatively, and in a fifth aspect, at least one of theplurality of anchor elements comprises a self-expanding frame.

In addition or alternatively, and in a sixth aspect, at least one of theplurality of anchor elements comprises a screw-type fastener, whereinrotation of a rotatable insert expands a distal portion of itsrespective anchor element.

In addition or alternatively, and in a seventh aspect, securing two ofthe plurality of anchor elements together forms a fold in the one layerof mitral valve leaflet tissue, the fold being disposed between the atleast two of the plurality of anchor elements.

In addition or alternatively, and in an eighth aspect, the securingelement is configured to be disposed around at least a portion of aperimeter of each of the at least two of the plurality of anchorelements.

In addition or alternatively, and in a ninth aspect, the securingelement comprises a shape memory material.

In addition or alternatively, and in a tenth aspect, the securingelement forms a closed loop around the at least two of the plurality ofanchor elements.

In addition or alternatively, and in an eleventh aspect, the securingelement comprises a magnetic attraction between each of the at least twoof the plurality of anchor elements.

In addition or alternatively, and in a twelfth aspect, a method oftreating mitral valve prolapse may comprise: percutaneously inserting adelivery catheter to a left atrium of a heart; securing a distal end ofthe delivery catheter to a mitral valve leaflet using a suction lumenextending through the delivery catheter; inserting a plurality of anchorelements into the mitral valve leaflet from the distal end of thedelivery catheter at spaced-apart locations; translating two of theplurality of anchor elements closer together; and securing the at leasttwo of the plurality of anchor elements together on one side of themitral valve leaflet.

In addition or alternatively, and in a thirteenth aspect, translatingtwo of the plurality of anchor elements closer together furthercomprises forming a fold in the mitral valve leaflet, the fold beingdisposed between the at least two of the plurality of anchor elements.

In addition or alternatively, and in a fourteenth aspect, the mitralvalve leaflet is released from the distal end of the delivery catheterafter inserting each anchor element, and the distal end of the deliverycatheter is re-secured to the mitral valve leaflet before inserting eachsubsequent anchor element into the mitral valve leaflet.

In addition or alternatively, and in a fifteenth aspect, the pluralityof anchor elements is inserted along lateral boundaries of prolapsedtissue of the mitral valve leaflet, such that the at least two of theplurality of anchor elements are disposed on opposing sides of theprolapsed tissue.

In addition or alternatively, and in a sixteenth aspect, inserting theplurality of anchor elements into the mitral valve leaflet includesinserting each anchor element through only a single thickness of themitral valve leaflet.

In addition or alternatively, and in a seventeenth aspect, a method oftreating mitral valve prolapse may comprise: percutaneously inserting adelivery catheter to a left atrium of a heart; securing a distal end ofthe delivery catheter to a mitral valve leaflet using a suction lumenextending through the delivery catheter; inserting two or more pairs ofanchor elements into the mitral valve leaflet from the distal end of thedelivery catheter at a first relative location, wherein the anchorelements of each pair of anchor elements are spaced apart from eachother at the first relative location; translating each pair of anchorelements to a second relative location, wherein the anchor elements ofeach pair of anchor elements are closer together than at the firstrelative location; and securing each pair of anchor elements together atthe second relative location on one side of the mitral valve leaflet.

In addition or alternatively, and in an eighteenth aspect, translatingeach pair of anchor elements to the second relative location furthercomprises forming a fold in the mitral valve leaflet, the fold beingdisposed between each pair of anchor elements.

In addition or alternatively, and in a nineteenth aspect, the mitralvalve leaflet is released from the distal end of the delivery catheterafter inserting each pair of anchor elements, and the distal end of thedelivery catheter is re-secured to the mitral valve leaflet beforeinserting each subsequent pair of anchor elements into the mitral valveleaflet.

In addition or alternatively, and in a twentieth aspect, the two or morepairs of anchor elements are disposed within lumens of the deliverycatheter other than the suction lumen prior to insertion into the mitralvalve leaflet.

The above summary of some embodiments, aspects, and/or examples is notintended to describe each embodiment or every implementation of thepresent disclosure. The figures and the detailed description whichfollows more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a partial cut-away view of an example heart;

FIG. 2 illustrates an example delivery catheter;

FIG. 3 illustrates an example anchor element;

FIG. 4 illustrates an example anchor element;

FIGS. 5-6 illustrate an example anchor element; and

FIGS. 7-17 illustrate aspects of a method of treating mitral valveprolapse.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention. However, in the interest ofclarity and ease of understanding, while every feature and/or elementmay not be shown in each drawing, the feature(s) and/or element(s) maybe understood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosedinvention are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device. Stillother relative terms, such as “axial”, “circumferential”,“longitudinal”, “lateral”, “radial”, etc. and/or variants thereofgenerally refer to direction and/or orientation relative to a centrallongitudinal axis of the disclosed structure or device.

The terms “extent” and/or “maximum extent” may be understood to mean agreatest measurement of a stated or identified dimension, while the term“minimum extent” may be understood to mean a smallest measurement of astated or identified dimension. For example, “outer extent” may beunderstood to mean a maximum outer dimension, “radial extent” may beunderstood to mean a maximum radial dimension, “longitudinal extent” maybe understood to mean a maximum longitudinal dimension, etc. Eachinstance of an “extent” may be different (e.g., axial, longitudinal,lateral, radial, circumferential, etc.) and will be apparent to theskilled person from the context of the individual usage. Generally, an“extent” or “maximum extent” may be considered a greatest possibledimension measured according to the intended usage. Alternatively, a“minimum extent” may be considered a smallest possible dimensionmeasured according to the intended usage. In some instances, an “extent”may generally be measured orthogonally within a plane and/orcross-section, but may be, as will be apparent from the particularcontext, measured differently—such as, but not limited to, angularly,radially, circumferentially (e.g., along an arc), etc.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent throughout the world. Some mammalian hearts (e.g., human,etc.) include four heart valves: a tricuspid valve 12, a pulmonary valve14, an aortic valve 16, and a mitral valve 18, as seen in an exampleheart 10 illustrated in FIG. 1. The purpose of the heart valves is tocontrol blood flow into the heart 10 from the inferior vena cava 24and/or the superior vena cava 26, through the heart 10, and out of theheart 10 into the major blood vessels connected to the heart 10, such asthe aorta 20, the pulmonary artery 22, for example. Each heart valve mayhave a plurality of valve leaflets configured to shift between an openconfiguration permitting fluid flow through the heart valve in anantegrade direction, and a closed configuration wherein free edges ofthe valve leaflets coapt to substantially prevent fluid flow through theheart valve in a retrograde direction. The heart 10 may also include aleft atrium 30, a left ventricle 40, a right atrium 50, and a rightventricle 60. The left ventricle 40 may include a first papillary muscle42 attached to and/or extending from a wall of the left ventricle 40, asecond papillary muscle 44 attached to and/or extending from the wall ofthe left ventricle 40, and a plurality of chordae 46 connecting thefirst papillary muscle 42 and the second papillary muscle 44 to theleaflets of the mitral valve 18. In a normally functioning heart valve,blood is permitted to pass or flow downstream through the heart valve(e.g., from an atrium to a ventricle, from a ventricle to an artery,etc.) when the heart valve is open (e.g., during diastole), and when theheart valve is closed (e.g., during systole), blood is prevented frompassing or flowing back upstream through the heart valve (e.g., from aventricle to an atrium, etc.). In some instances, when regurgitation(e.g., mitral regurgitation) occurs, a heart valve (e.g., the mitralvalve 18) fails to open and/or close properly such that blood ispermitted to pass or flow back upstream through the heart valve (e.g.,from a ventricle to an atrium, etc.). In some cases, the defective heartvalve may have leaflets that may not close, or may not be capable ofclosing, completely. In some instances, secondary or functional mitralregurgitation may be a secondary effect of left ventricular dysfunction,where left ventricular dilatation and/or distension caused by ischemicor idiopathic cardiomyopathy, for example, results in annular dilatationand/or distension of the left ventricle 40 and papillary muscledisplacement with subsequent leaflet tethering and insufficientcoaptation of the mitral leaflets during systole. In some instances,degenerative mitral regurgitation may involve redundant excessive tissuein part of the heart valve and/or the heart valve leaflets (e.g., mitralvalve prolapse). Surgical methods of treating degenerative mitralregurgitation may include resection of the prolapsed segment andplacement of an annuloplasty ring to stabilize the valve (in many casesbut not necessarily every case). However, such methods may be invasiveand/or unsuitable for frail patients who are not qualified surgicalcandidates. Disclosed herein are apparatus, medical devices, and/ormethods that may be used to diagnose, treat, and/or repair a portion ofthe cardiovascular system. One possible remedy is percutaneous procedurewhich may isolate redundant leaflet tissue without removing any of thetissue, thereby permitting the heart valve leaflets to properly closethe heart valve to the passage of blood. The disclosed mitral valveleaflet repair system, method(s), and associated medical device(s) maybe performed/used percutaneously via minimally-invasive intravasculartechniques, or in an alternative method, using open-heart surgicalmethods. The device(s) and method(s) disclosed herein may also provide anumber of additional desirable features and/or benefits as described inmore detail below. For the purpose of this disclosure, the discussionbelow is directed toward repairing the mitral valve 18 and will be sodescribed in the interest of brevity. This, however, is not intended tobe limiting as the skilled person will recognize that the followingdiscussion may also apply to the aortic valve or another heart valvewith no or minimal changes to the structure and/or scope of thedisclosure.

FIG. 2 illustrates an example delivery catheter 100 of a mitral valveleaflet repair system. The mitral valve leaflet repair system mayinclude a plurality of anchor elements 130, shown schematically in FIG.2 as an arrowhead, wherein each of the plurality of anchor elements 130is configured to extend through one layer of mitral valve leaflettissue, as will be described below. The mitral valve leaflet repairsystem may further comprise a securing element 140 (e.g., FIGS. 13-15),also described in more detail below, configured to secure at least twoof the plurality of anchor elements 130 together on one side (e.g., onan atrial side, on a ventricular side) of the mitral valve leaflettissue.

The delivery catheter 100 may include at least one lumen extendingproximally from a distal end 102 of the delivery catheter 100. Theplurality of anchor elements 130 may be disposed within the at least onelumen, as shown in FIG. 2 for example. In some embodiments, the at leastone lumen may comprise a suction lumen 110 configured to grasp and/orhold, and/or to secure the distal end 102 of the delivery catheter 100to, a surface (e.g., a “top” or atrial surface) of a mitral valveleaflet during a mitral valve leaflet repair procedure. The suctionlumen 110 may be in fluid communication with a source of suction. Insome embodiments, an alternative gripping mechanism, for example aclaw-like mechanism, may be used to hold the mitral valve leaflet duringa mitral valve leaflet repair procedure. In some embodiments, at leastone of the plurality of anchor elements 130 may be disposed within thesuction lumen 110, as seen in phantom in FIG. 2.

In some embodiments, the at least one lumen may further comprise aplurality of anchor lumens 120. At least one of the plurality of anchorelements 130 may be disposed within each of the plurality of anchorlumens 120, as seen in FIG. 2. In some embodiments, the suction lumen110 may also be and/or function as one of the plurality of anchor lumens120. In some embodiments, the delivery catheter 100 may comprise asingle lumen extending from a proximal end to the distal end 102,wherein the single lumen functions as both a suction lumen and an anchorlumen. In some embodiments, the plurality of anchor elements 130 may bedisposed within the single lumen. In some embodiments, at least one ofthe plurality of anchor elements 130 may be disposed within each of twoor more of the plurality of anchor lumens 120.

In at least some embodiments, each of the at least one lumen may haveand/or include a pushing member and/or mechanism (not shown) configuredto advance the plurality of anchor elements 130 distally out of thedelivery catheter 100 and into and/or through one layer and/or a singlethickness of mitral valve leaflet tissue. In some embodiments, each ofthe plurality of anchor lumens 120 may have and/or include a pushingmember and/or mechanism configured to advance the plurality of anchorelements 130 distally out of the delivery catheter 100 and into and/orthrough one layer and/or a single thickness of mitral valve leaflettissue. In some embodiments, the suction lumen 110 may have and/orinclude a pushing member and/or mechanism configured to advance theplurality of anchor elements 130 distally out of the delivery catheter100 and into and/or through one layer and/or a single thickness ofmitral valve leaflet tissue. In some embodiments, each pushing memberand/or mechanism may be configured to advance one of the plurality ofanchor elements 130 distally out of the delivery catheter 100 and intoand/or through one layer and/or a single thickness of mitral valveleaflet tissue. In some embodiments, each pushing member and/ormechanism may be configured to advance only one of the plurality ofanchor elements 130 distally out of the delivery catheter 100 and intoand/or through one layer and/or a single thickness of mitral valveleaflet tissue. In some embodiments, each pushing member and/ormechanism may be configured to advance more than one of the plurality ofanchor elements 130 distally out of the delivery catheter 100 and intoand/or through one layer and/or a single thickness of mitral valveleaflet tissue.

In some embodiments, each pushing member and/or mechanism may extendthrough its respective lumen. In some embodiments, each pushing memberand/or mechanism may extend out proximally past the proximal end of thedelivery catheter 100.

In some embodiments, each pushing member and/or mechanism may bedisposed entirely within the delivery catheter 100. In some embodiments,each pushing member and/or mechanism may be disposed entirely within thedelivery catheter 100, except for an activation and/or actuation meansproximate the proximal end of the delivery catheter 100. Variouscombinations of these features are also contemplated. Some suitable butnon-limiting materials for the delivery catheter 100, the pushing memberand/or mechanism, and/or other associated components, for examplemetallic materials, polymer materials, composite materials, etc., aredescribed below.

FIG. 3 illustrates an example anchor element 130 comprising a rivet. Inat least some embodiments, the anchor element 130 may be a rivet havinga fixed configuration.

In some embodiments, the anchor element 130 may include a flattened headportion 132, a pointed and/or sharpened tip portion 134, and a shaftportion 136 spacing apart and connecting the flattened head portion 132and the pointed and/or sharpened tip portion 134. In some embodiments,the anchor element 130 may include an upper head portion 133 and anupper shaft portion 131 extending proximally and/or away from theflattened head portion 132 and/or the shaft portion 136, thereby spacingapart and connecting the flattened head portion 132 and the upper headportion 133. In at least some embodiments, the upper head portion 133may have a generally flattened shape and/or may be orientedsubstantially parallel to the flattened head portion 132. In someembodiments, the flattened head portion 132 and/or the upper headportion 133 may extend generally perpendicular to and/or radiallyoutward from the shaft portion 136 and/or the upper shaft portion 131.

The pointed and/or sharpened tip portion 134 may be angled and/ortapered radially inward in a distal direction and/or away from theflattened head portion 132, and may be configured to be advanced intoand/or through the mitral valve leaflet tissue. The flattened headportion 132 may be configured to engage and/or rest against one side(e.g., on an atrial side, on a ventricular side) of the mitral valveleaflet tissue, for example the atrial side of the mitral valve leaflettissue. In some embodiments, the shaft portion 136 may be configured toextend through the mitral valve leaflet tissue such that only one layerand/or a single thickness of the mitral valve leaflet tissue is disposedbetween the flattened head portion 132 and the pointed and/or sharpenedtip portion 134. In at least some embodiments, the flattened headportion 132 may have a maximum outer extent and/or diameter greater thana maximum outer extent and/or diameter of the pointed and/or sharpenedtip portion 134, wherein the maximum outer extent and/or diameter of thepointed and/or sharpened tip portion 134 may be greater than a maximumouter extent and/or diameter of the shaft portion 136. In someembodiments, a maximum outer extent and/or diameter of the upper headportion 133 may be the same as and/or less than the maximum outer extentand/or diameter of the flattened head portion 132. Other forms of fixedor expandable rivets or rivet-like fasteners, a pop rivet for example,may also be used. Some suitable but non-limiting materials for theanchor element 130, for example metallic materials, polymer materials,composite materials, etc., are described below.

FIG. 4 illustrates an alternative anchor element 230 comprising anexpanding frame. In some embodiments, the expanding frame may be similarin design and/or structure to expanding frames used in stents, anchoringstructures, filters, occlusive elements, etc. The anchor element 230 maybe used in substantially the same manner, placement, and usage as theanchor element 130, unless explicitly noted herein. The anchor element230 may be configured to shift between an elongated and collapseddelivery configuration (not shown), suitable for disposal in and/ordelivery through the plurality of anchor lumens 120, and a radiallyexpanded deployed configuration (e.g., FIG. 4). The anchor element 230may include a proximal head portion 232, a distal tip portion 234, and ashaft portion 236 spacing apart and connecting the proximal head portion232 and the distal tip portion 234. In at least some embodiments, thedistal tip portion 234 may be pointed and/or sharpened to facilitateadvancement through the mitral valve leaflet tissue. The proximal headportion 232 and the distal tip portion 234 may each be configured toradially expand from the elongated and collapsed delivery configurationto the radially expanded deployed configuration after being advanced outof its respective anchor lumen 120. In some embodiments, the shaftportion 236 may be configured to extend through the mitral valve leaflettissue such that only one layer and/or a single thickness of the mitralvalve leaflet tissue is disposed between the proximal head portion 232and the distal tip portion 234. The anchor element 230 may be configuredto longitudinally shorten in overall length when shifting from theelongated and collapsed delivery configuration to the radially expandeddeployed configuration, thereby capturing and/or pinching the mitralvalve leaflet tissue between the proximal head portion 232 and thedistal tip portion 234.

In some embodiments, the proximal head portion 232 and/or the distal tipportion 234 may radially expand to generally flattened shape, similar tothe flattened head portion 132 above. The proximal head portion 232 maybe configured to engage and/or rest against the atrial surface of themitral valve leaflet tissue and/or the distal tip portion 234 may beconfigured to engage and/or rest against a ventricular surface of themitral valve leaflet tissue. In some embodiments, the proximal headportion 232 may expand to a maximum outer extent and/or diameter greaterthan a maximum outer extent and/or diameter of the distal tip portion234, wherein the maximum outer extent and/or diameter of the distal tipportion 234 may be greater than a maximum outer extent and/or diameterof the shaft portion 236. In some embodiments, the maximum outer extentand/or diameter of the proximal head portion 232 and the maximum outerextent and/or diameter of the distal tip portion 234 may besubstantially similar and/or the same. In some embodiments, the anchorelement 230 may be self-expandable, mechanically-expandable, and/orcombinations thereof. In some embodiments, the anchor element 230 may beformed from a shape memory material. Some suitable but non-limitingmaterials for the anchor element 230, for example metallic materials,polymer materials, composite materials, etc., are described below.

FIGS. 5 and 6 illustrate an alternative anchor element 330 comprising ascrew-type fastener. The anchor element 330 may be configured to shiftfrom a delivery configuration (e.g., FIG. 5) to a deployed configuration(e.g., FIG. 6). The anchor element 330 may include a proximal headportion 332, a distal portion 334, and a rotatable insert 338 rotatablyand threadably connected to the proximal head portion 332 and/or thedistal portion 334. In the delivery configuration, the distal portion334 may include a distal taper radially inward extending from agenerally uniform diameter shaft portion 336, and the rotatable insert338 may extend through and proximally from the proximal head portion332. Clockwise rotation of the rotatable insert 338 relative to theproximal head portion 332, the distal portion 334, and/or the shaftportion 336 of the anchor element 330, via a threaded connection forexample, may advance the rotatable insert 338 distally through theproximal head portion 332 and/or into the shaft portion 336 and/or thedistal portion 334. Clockwise rotation of the rotatable insert 338relative to the proximal head portion 332, the distal portion 334,and/or the shaft portion 336 of the anchor element 330 may radiallyand/or laterally expand, and/or longitudinally shorten, the distalportion 334 of the anchor element 330, thereby shifting the anchorelement 330 from the delivery configuration to the deployedconfiguration.

Counterclockwise rotation of the rotatable insert 338 relative to theproximal head portion 332, the distal portion 334, and/or the shaftportion 336 of the anchor element 330 may reverse the shift from thedeployed configuration toward the delivery configuration.

The proximal head portion 332 of the anchor element 330 may beconfigured to engage and/or rest against one side (e.g., on an atrialside, on a ventricular side) of the mitral valve leaflet tissue. Thedistal portion 334 of the anchor element 330 may be angled and/ortapered radially inward in a distal direction and/or away from theproximal head portion 332, and may be configured to be advanced intoand/or through the mitral valve leaflet tissue. In at least someembodiments, the distal portion 334 of the anchor element 330 may bepointed and/or sharpened to facilitate advancement through the mitralvalve leaflet tissue. In some embodiments, the shaft portion 336 of theanchor element 330 may be configured to extend through the mitral valveleaflet tissue such that only one layer and/or a single thickness of themitral valve leaflet tissue is disposed between the proximal headportion 332 and the distal portion 334 of the anchor element 330. In atleast some embodiments, the proximal head portion 332 of the anchorelement 330 may have a maximum outer extent and/or diameter greater thana maximum outer extent and/or diameter of the distal portion 334 of theanchor element 330, wherein the maximum outer extent and/or diameter ofthe distal portion 334 of the anchor element 330 in the deployedconfiguration may be greater than a maximum outer extent and/or diameterof the shaft portion 336 of the anchor element 330. Some suitable butnon-limiting materials for the anchor element 330, for example metallicmaterials, polymer materials, composite materials, etc., are describedbelow.

FIGS. 7-15 illustrate aspects of an example method of treating mitralvalve prolapse. For example, the method may include percutaneouslyinserting a delivery catheter 100 through a vasculature to the leftatrium 30 of the heart 10. In at least some embodiments, access to theleft atrium 30 may be achieved using a transseptal approach, which mayinvolve transiting the septum of the heart 10 between the left atrium 30and the right atrium 50. The delivery catheter 100 may be advanced intoright atrium 50 of the heart 10 through the inferior vena cava 24 or thesuperior vena cava 26 before transiting the septum and advancing intothe left atrium 30, as shown in FIG. 7 for example. Alternativepercutaneous approaches, through the aorta for example, may also beused. FIG. 8 illustrates the mitral valve 18 in a prolapsed condition,wherein a mitral valve leaflet 17 may include redundant excessive and/orprolapsed tissue in part of the mitral valve 18 that prevents properclosure and/or coaptation of the mitral valve leaflets 17. The redundantexcessive and/or prolapsed tissue may be seen in FIG. 8 (and subsequentfigures) between lateral boundaries 19, designated by broken lines.

After inserting the delivery catheter 100 into the left atrium 30 of theheart 10, the method may include securing the distal end 102 of thedelivery catheter 100 to the mitral valve leaflet 17 using the suctionlumen 110 extending through the delivery catheter 100, as shown in FIG.9 for example. The method may further include inserting a plurality ofanchor elements 130 (e.g., 230, 330) into the mitral valve leaflet 17from the distal end 102 of the delivery catheter 100 at spaced-apartlocations, as seen in FIGS. 9 and 10. In some embodiments, the mitralvalve leaflet 17 may be released from the distal end 102 of the deliverycatheter 100 after inserting each anchor element 130, and the distal end102 of the delivery catheter 100 may be re-secured to the mitral valveleaflet 17 before inserting each subsequent anchor element 130 into themitral valve leaflet 17. The plurality of anchor elements 130 may beinserted along the lateral boundaries 19 of the prolapsed tissue of themitral valve leaflet 17, as seen in FIG. 10, such that two of theplurality of anchor elements 130 are disposed on opposing sides of theprolapsed tissue of the mitral valve leaflet 17. In at least someembodiments, inserting the plurality of anchor elements 130 into themitral valve leaflet 17 includes inserting each anchor element 130through only a single layer or thickness of the mitral valve leaflet 17.

The method may include translating two of the plurality of anchorelements 130 closer together, as shown in FIG. 11, wherein translatingtwo of the plurality of anchor elements 130 closer together furthercomprises forming a fold 171 in the mitral valve leaflet 17, the fold171 being disposed between the at least two of the plurality of anchorelements 130, as seen in FIG. 12 for example, which illustrates across-section taken along line 12-12 in FIG. 11. In some embodiments,the fold 171 may comprise a single fold, as illustrated, or the fold 171may comprise a plurality of folds forming an accordion-like or pleatedstructure. In some embodiments, the fold 171 may initiate at the lateralboundaries 19, although this is not strictly necessary. Next, the methodmay include securing the at least two of the plurality of anchorelements 130 together on one side (e.g., on an atrial side, on aventricular side) of the mitral valve leaflet 17. In some embodiments,securing two of the plurality of anchor elements 130 together forms thefold 171 in the one layer of mitral valve leaflet tissue, the fold 171being disposed between the at least two of the plurality of anchorelements 130. As show in FIG. 13, in some embodiments, the mitral valveleaflet repair system may include a securing element 140. In someembodiments, the securing element 140 may be delivered to the mitralvalve 18 and/or the plurality of anchor elements 130 through thedelivery catheter 100, the suction lumen 110, and/or one of theplurality of anchor lumens 120. Alternatively, the securing element 140may be delivered using a separate delivery device, either alone or inconjunction with the delivery catheter 100. In some embodiments, thesecuring element 140 may be configured to be disposed around at least aportion of a perimeter of each of the at least two of the plurality ofanchor elements 130. In some embodiments, the securing element 140 maybe disposed around the upper shaft portion 131 of each anchor element130 between the flattened head portion 132 and the upper head portion133, as seen in FIGS. 13-15. In some embodiments, the securing element140 may be configured to translate each pair of the at least two of theplurality of anchor elements 130 closer together. In at least someembodiments, the securing element 140 may comprise a shape memorymaterial. In some embodiments, the securing element 140 may comprise asuture, a wire, and/or a filament. In some embodiments, the securingelement 140 may form a closed loop around the at least two of theplurality of anchor elements 130 (e.g., FIG. 14). In some embodiments,the securing element 140 may comprise a magnetic attraction between eachof the at least two of the plurality of anchor elements 130. Forexample, each anchor element 130 may include and/or be formed from amagnetic material, may include a magnetic element disposed within theanchor element 130 (e.g., within the flattened head portion 132, withinthe pointed and/or sharpened tip portion 134, and/or within the shaftportion 136, etc.). Some suitable but non-limiting materials for thesecuring element 140, for example metallic materials, polymer materials,composite materials, etc., are described below.

In some embodiments, the at least two of the plurality of anchorelements 130 may be secured together on only one side of the mitralvalve leaflet 17 (e.g., the atrial side, the ventricular side, etc.)and/or the mitral valve leaflet tissue. In some embodiments, the atleast two of the plurality of anchor elements 130 may be securedtogether on both sides (e.g., the atrial side and the ventricular side)of the mitral valve leaflet 17 and/or the mitral valve leaflet tissue.In some embodiments, the at least two of the plurality of anchorelements 130 may be secured together on only one side of the mitralvalve leaflet 17 without the securing element 140 passing through themitral valve leaflet 17 and/or the mitral valve leaflet tissue. In someembodiments, the at least two of the plurality of anchor elements 130may be secured together on both sides of the mitral valve leaflet 17without the securing element 140 passing through the mitral valveleaflet 17 and/or the mitral valve leaflet tissue. In some embodiments,the mitral valve leaflet repair system may include at least two securingelements 140, wherein a first securing element 140 is disposed on theatrial side of the mitral valve leaflet 17 and/or the mitral valveleaflet tissue, and a second securing element 140 is disposed on theventricular side of the mitral valve leaflet 17 and/or the mitral valveleaflet tissue. Various combinations of the securing element 140described herein may be used in embodiments having more than onesecuring element 140.

In an alternative embodiment, the method may include inserting two ormore pairs of anchor elements 130 into the mitral valve leaflet 17 fromthe distal end 102 of the delivery catheter 100 at a first relativelocation (seen in FIG. 10 for example), wherein the anchor elements 130of each pair of anchor elements 130 are spaced apart from each other atthe first relative location. The two or more pairs of anchor elements130 may be disposed within lumens of the delivery catheter 100 otherthan the suction lumen 110 (for example, at least one of the pluralityof anchor lumens 120, etc.) prior to insertion into the mitral valveleaflet 17. In some embodiments, each pair of anchor elements 130 may bedisposed within a corresponding pair of anchor lumens 120 disposedopposite each other relative to the suction lumen 110, and/or onopposing sides of the suction lumen 110.

The mitral valve leaflet 17 may be released from the distal end 102 ofthe delivery catheter 100 after inserting each pair of anchor elements130, and the distal end 102 of the delivery catheter 100 may bere-secured to the mitral valve leaflet 17 before inserting eachsubsequent pair of anchor elements 130 into the mitral valve leaflet 17.Each pair of anchor elements 130 may be inserted along the lateralboundaries 19 of the prolapsed tissue of the mitral valve leaflet 17,such that each anchor element of each pair of anchor elements 130 isdisposed on opposing sides of the prolapsed tissue of the mitral valveleaflet 17. In at least some embodiments, inserting two of more pairs ofanchor elements 130 into the mitral valve leaflet 17 includes insertingeach pair of anchor elements 130 through only a single layer orthickness of the mitral valve leaflet 17.

An alternative method may include translating each pair of anchorelements 130 to a second relative location, as seen in FIG. 11 forexample, wherein the anchor elements 130 of each pair of anchor elements130 are closer together than at the first relative location. In someembodiments, the securing element 140 may be configured to translateeach pair of anchor elements 130 to the second relative location.Translating each pair of anchor elements 130 to the second relativelocation may further comprise forming a fold 171 in the mitral valveleaflet 17, the fold 171 being disposed between each pair of anchorelements 130, as seen in FIG. 12. In some embodiments, the method mayinclude securing each pair of anchor elements 130 together at the secondrelative location on one side of the mitral valve leaflet 17, as seen inFIGS. 13-15, with the fold 171 being disposed between each pair ofanchor elements 130.

In some embodiments, the securing element 140 may be configured to bedisposed around at least a portion of a perimeter of each pair of anchorelements 130. In some embodiments, the securing element 140 may bedisposed around the upper shaft portion 131 of each anchor element 130between the flattened head portion 132 and the upper head portion 133,as seen in FIGS. 13-15. In at least some embodiments, the securingelement 140 may comprise a shape memory material. In some embodiments,the securing element 140 may comprise a suture, a wire, and/or afilament. As shown in FIG. 14, the securing element 140 may form aclosed loop around each pair of anchor elements 130, the closed loopbeing held closed and/or secured by a securement member 142. Thesecurement member 142 may comprise a knot, a cinch, a crimp, or othersuitable means of securing the securing element 140 to itself, wherenecessary. In some embodiments, the securing element 140 may comprise amagnetic attraction between each pair of anchor elements 130. Forexample, each anchor element 130 may include and/or be formed from amagnetic material, may include a magnetic element disposed within theanchor element 130 (e.g., within the flattened head portion 132, withinthe pointed and/or sharpened tip portion 134, and/or within the shaftportion 136, etc.).

Some additional details are illustrated in FIG. 15, which iscross-section taken along line 15-15 of FIG. 14. The configuration(s)and/or general arrangement(s) shown in FIG. 15 may also apply to theembodiment(s) shown in FIG. 13. In some embodiments, each pair of anchorelements 130 may be secured together on only one side of the mitralvalve leaflet 17 (e.g., the atrial side, the ventricular side, etc.)and/or the mitral valve leaflet tissue. In some embodiments, each pairof anchor elements 130 may be secured together on both sides (e.g., theatrial side and the ventricular side) of the mitral valve leaflet 17and/or the mitral valve leaflet tissue. In some embodiments, each pairof anchor elements 130 may be secured together on only one side of themitral valve leaflet 17 without the securing element 140 passing throughthe mitral valve leaflet 17 and/or the mitral valve leaflet tissue. Insome embodiments, each pair of anchor elements 130 may be securedtogether on both sides of the mitral valve leaflet 17 without thesecuring element 140 passing through the mitral valve leaflet 17 and/orthe mitral valve leaflet tissue. In some embodiments, the mitral valveleaflet repair system may include at least two securing elements 140,wherein a first securing element 140 is disposed on the atrial side ofthe mitral valve leaflet 17 and/or the mitral valve leaflet tissue, anda second securing element 140 is disposed on the ventricular side of themitral valve leaflet 17 and/or the mitral valve leaflet tissue. Variouscombinations of the securing element 140 described herein may be used inembodiments having more than one securing element 140.

In another alternative embodiment, the method may include inserting twoor more pairs of anchor elements 130 into the mitral valve leaflet 17from the distal end 102 of the delivery catheter 100 at a first relativelocation, as seen in FIG. 16, wherein the anchor elements 130 of eachpair of anchor elements 130 are spaced apart from each other at thefirst relative location. The two or more pairs of anchor elements 130may be disposed within lumens of the delivery catheter 100 other thanthe suction lumen 110 (for example, at least one of the plurality ofanchor lumens 120, etc.) prior to insertion into the mitral valveleaflet 17. In some embodiments, each pair of anchor elements 130 may bedisposed within a corresponding pair of anchor lumens 120 disposedopposite each other relative to the suction lumen 110, and/or onopposing sides of the suction lumen 110.

The mitral valve leaflet 17 may be released from the distal end 102 ofthe delivery catheter 100 after inserting each pair of anchor elements130, and the distal end 102 of the delivery catheter 100 may bere-secured to the mitral valve leaflet 17 before inserting eachsubsequent pair of anchor elements 130 into the mitral valve leaflet 17.Each anchor element of each pair of anchor elements 130 may be insertedand/or positioned along the lateral boundaries 19 of the prolapsedtissue of the mitral valve leaflet 17. In some embodiments, a linkingelement 150 may extend between adjacent anchor elements 130 along eachof the lateral boundaries 19. As such, there may be at least one linkingelement 150 positioned along and/or generally parallel to each of thelateral boundaries 19. In at least some embodiments, inserting two ofmore pairs of anchor elements 130 into the mitral valve leaflet 17includes inserting each pair of anchor elements 130 through only asingle layer or thickness of the mitral valve leaflet 17. In someembodiments, there may be a linking element 150 disposed on each side(e.g., the atrial side and the ventricular side) of the mitral valveleaflet 17.

An alternative method may include translating each pair of anchorelements 130 to a second relative location, as seen in FIG. 17 forexample, wherein the anchor elements 130 of each pair of anchor elements130 are closer together than at the first relative location. Translatingeach pair of anchor elements 130 to the second relative location mayfurther comprise forming a fold 171 in the mitral valve leaflet 17. Insome embodiments, the method may include securing the linking element(s)150 between adjacent anchor elements 130 along each of the lateralboundaries 19 together to bring each pair of anchor elements 130together at the second relative location on one side of the mitral valveleaflet 17 with the securing element 140, as seen in FIG. 17.

In some embodiments, the securing element 140 may be configured to bedisposed around at least a portion of a perimeter of each pair of anchorelements 130, in the manner described above. For example, in someembodiments, the securing element 140 may be disposed around the uppershaft portion 131 of each anchor element 130 between the flattened headportion 132 and the upper head portion 133 (e.g., FIGS. 13-15). In someembodiments, the securing element 140 may comprise a shape memorymaterial. In some embodiments, the securing element 140 may comprise asuture, a wire, and/or a filament. In some embodiments, the securingelement 140 may form a closed loop around each of the linking elements150 (e.g., FIG. 17).

In some embodiments, each pair of anchor elements 130 and/or the linkingelements 150 may be secured together on only one side of the mitralvalve leaflet 17 (e.g., the atrial side, the ventricular side, etc.)and/or the mitral valve leaflet tissue. In some embodiments, each pairof anchor elements 130 and/or the linking elements 150 may be securedtogether on both sides (e.g., the atrial side and the ventricular side)of the mitral valve leaflet 17 and/or the mitral valve leaflet tissue.In some embodiments, each pair of anchor elements 130 and/or the linkingelements 150 may be secured together on only one side of the mitralvalve leaflet 17 without the securing element 140 passing through themitral valve leaflet 17 and/or the mitral valve leaflet tissue. In someembodiments, each pair of anchor elements 130 and/or the linkingelements 150 may be secured together on both sides of the mitral valveleaflet 17 without the securing element 140 passing through the mitralvalve leaflet 17 and/or the mitral valve leaflet tissue. In someembodiments, the mitral valve leaflet repair system may include at leasttwo securing elements 140, wherein a first securing element 140 isdisposed on the atrial side of the mitral valve leaflet 17 and/or themitral valve leaflet tissue, and a second securing element 140 isdisposed on the ventricular side of the mitral valve leaflet 17 and/orthe mitral valve leaflet tissue. Various combinations of the securingelement 140 described herein may be used in embodiments having more thanone securing element 140. The materials that can be used for the variouscomponents of the mitral valve leaflet repair system, the deliverycatheter 100, the anchor elements 130/230/330, the securing elements140, the linking elements 150, etc. (and/or other systems or componentsdisclosed herein) and the various elements thereof disclosed herein mayinclude those commonly associated with medical devices. For simplicitypurposes, the following discussion makes reference to the mitral valveleaflet repair system, the delivery catheter 100, the anchor elements130/230/330, the securing elements 140, the linking elements 150, etc.However, this is not intended to limit the devices and methods describedherein, as the discussion may be applied to other elements, members,components, or devices disclosed herein, such as, but not limited to,the upper shaft portion 131, the head portion 132/232/332, the upperhead portion 133, the distal portion 134/234/334, the shaft portion136/236/336, the rotatable insert 338, etc. and/or elements orcomponents thereof.

In some embodiments, the mitral valve leaflet repair system, thedelivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc., and/or components thereofmay be made from a metal, metal alloy, polymer (some examples of whichare disclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable metals and metal alloys include stainless steel, such as 444V,444L, and 314LV stainless steel; mild steel; nickel-titanium alloy suchas linear-elastic and/or super-elastic nitinol; other nickel alloys suchas nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;platinum, platinum-iridium, other platinum alloys; palladium; gold;combinations thereof;

and the like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the mitral valveleaflet repair system, the delivery catheter 100, the anchor elements130/230/330, the securing elements 140, the linking elements 150, etc.,and/or components thereof, may also be doped with, made of, or otherwiseinclude a radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. This relatively bright image aids a user in determining thelocation of the mitral valve leaflet repair system, the deliverycatheter 100, the anchor elements 130/230/330, the securing elements140, the linking elements 150, etc. Some examples of radiopaquematerials can include, but are not limited to, gold, platinum,palladium, tantalum, tungsten alloy, polymer material loaded with aradiopaque filler, and the like. Additionally, other radiopaque markerbands and/or coils may also be incorporated into the design of themitral valve leaflet repair system, the delivery catheter 100, theanchor elements 130/230/330, the securing elements 140, the linkingelements 150, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the mitral valve leaflet repair system,the delivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc. For example, the mitralvalve leaflet repair system, the delivery catheter 100, the anchorelements 130/230/330, the securing elements 140, the linking elements150, etc., and/or components or portions thereof, may be made of amaterial that does not substantially distort the image and createsubstantial artifacts (e.g., gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an MRI image. The mitral valve leaflet repair system, thedelivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc., or portions thereof, mayalso be made from a material that the MRI machine can image. Somematerials that exhibit these characteristics include, for example,tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such asELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenumalloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, andthe like, and others.

In some embodiments, the mitral valve leaflet repair system, thedelivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc., and/or portions thereof,may be made from or include a polymer or other suitable material. Someexamples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane (for example,Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),Marlex high-density polyethylene, Marlex low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, polyurethane silicone copolymers (forexample, ElastEon® from Aortech Biomaterials or ChronoSil® fromAdvanSource Biomaterials), biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments, the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the mitral valve leaflet repair system, thedelivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc. may include and/or beformed from a textile material. Some examples of suitable textilematerials may include synthetic yarns that may be flat, shaped, twisted,textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarnssuitable for use in the present invention include, but are not limitedto, polyesters, including polyethylene terephthalate (PET) polyesters,polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls,polymethylacetates, polyamides, naphthalene dicarboxylene derivatives,natural silk, and polytetrafluoroethylenes. Moreover, at least one ofthe synthetic yarns may be a metallic yarn or a glass or ceramic yarn orfiber. Useful metallic yarns include those yarns made from or containingstainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-basedalloy. The yarns may further include carbon, glass or ceramic fibers.Desirably, the yarns are made from thermoplastic materials including,but not limited to, polyesters, polypropylenes, polyethylenes,polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like.The yarns may be of the multifilament, monofilament, or spun-types. Thetype and denier of the yarn chosen may be selected in a manner whichforms a biocompatible and implantable prosthesis and, more particularly,a vascular structure having desirable properties.

In some embodiments, the mitral valve leaflet repair system, thedelivery catheter 100, the anchor elements 130/230/330, the securingelements 140, the linking elements 150, etc. may include and/or betreated with a suitable therapeutic agent. Some examples of suitabletherapeutic agents may include anti-thrombogenic agents (such asheparin, heparin derivatives, urokinase, and PPack (dextrophenylalanineproline arginine chloromethylketone)); anti-proliferative agents (suchas enoxaparin, angiopeptin, monoclonal antibodies capable of blockingsmooth muscle cell proliferation, hirudin, and acetylsalicylic acid);anti-inflammatory agents (such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-mitotic agents (such aspaclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,epothilones, endostatin, angiostatin and thymidine kinase inhibitors);anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGDpeptide-containing compound, heparin, anti-thrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, andtick antiplatelet peptides); vascular cell growth promoters (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A mitral valve leaflet repair system, comprising:a delivery catheter having at least one lumen extending proximally froma distal end of the delivery catheter; a plurality of anchor elementsdisposed within the at least one lumen, each of the plurality of anchorelements being configured to extend through one layer of mitral valveleaflet tissue; and a securing element configured to secure at least twoof the plurality of anchor elements together on one side of the mitralvalve leaflet tissue; wherein the at least one lumen comprises a suctionlumen configured to grasp a mitral valve leaflet prior to extending theplurality of anchor elements through one layer of mitral valve leaflettissue.
 2. The mitral valve leaflet repair system of claim 1, whereinthe at least one lumen further comprises a plurality of anchor lumens,wherein at least one of the plurality of anchor elements is disposedwithin each of two or more of the plurality of anchor lumens.
 3. Themitral valve leaflet repair system of claim 1, wherein at least one ofthe plurality of anchor elements is disposed within the suction lumen.4. The mitral valve leaflet repair system of claim 1, wherein at leastone of the plurality of anchor elements comprises a rivet.
 5. The mitralvalve leaflet repair system of claim 1, wherein at least one of theplurality of anchor elements comprises a self-expanding frame.
 6. Themitral valve leaflet repair system of claim 1, wherein at least one ofthe plurality of anchor elements comprises a screw-type fastener,wherein rotation of a rotatable insert expands a distal portion of itsrespective anchor element.
 7. The mitral valve leaflet repair system ofclaim 1, wherein securing two of the plurality of anchor elementstogether forms a fold in the one layer of mitral valve leaflet tissue,the fold being disposed between the at least two of the plurality ofanchor elements.
 8. The mitral valve leaflet repair system of claim 1,wherein the securing element is configured to be disposed around atleast a portion of a perimeter of each of the at least two of theplurality of anchor elements.
 9. The mitral valve leaflet repair systemof claim 8, wherein the securing element comprises a shape memorymaterial.
 10. The mitral valve leaflet repair system of claim 8, whereinthe securing element forms a closed loop around the at least two of theplurality of anchor elements.
 11. The mitral valve leaflet repair systemof claim 1, wherein the securing element comprises a magnetic attractionbetween each of the at least two of the plurality of anchor elements.12. A method of treating mitral valve prolapse, comprising:percutaneously inserting a delivery catheter to a left atrium of aheart; securing a distal end of the delivery catheter to a mitral valveleaflet using a suction lumen extending through the delivery catheter;inserting a plurality of anchor elements into the mitral valve leafletfrom the distal end of the delivery catheter at spaced-apart locations;translating two of the plurality of anchor elements closer together; andsecuring the at least two of the plurality of anchor elements togetheron one side of the mitral valve leaflet.
 13. The method of claim 12,wherein translating two of the plurality of anchor elements closertogether further comprises forming a fold in the mitral valve leaflet,the fold being disposed between the at least two of the plurality ofanchor elements.
 14. The method of claim 12, wherein the mitral valveleaflet is released from the distal end of the delivery catheter afterinserting each anchor element, and the distal end of the deliverycatheter is re-secured to the mitral valve leaflet before inserting eachsubsequent anchor element into the mitral valve leaflet.
 15. The methodof claim 12, wherein the plurality of anchor elements is inserted alonglateral boundaries of prolapsed tissue of the mitral valve leaflet, suchthat the at least two of the plurality of anchor elements are disposedon opposing sides of the prolapsed tissue.
 16. The method of claim 12,wherein inserting the plurality of anchor elements into the mitral valveleaflet includes inserting each anchor element through only a singlethickness of the mitral valve leaflet.
 17. A method of treating mitralvalve prolapse, comprising: percutaneously inserting a delivery catheterto a left atrium of a heart; securing a distal end of the deliverycatheter to a mitral valve leaflet using a suction lumen extendingthrough the delivery catheter; inserting two or more pairs of anchorelements into the mitral valve leaflet from the distal end of thedelivery catheter at a first relative location, wherein the anchorelements of each pair of anchor elements are spaced apart from eachother at the first relative location; translating each pair of anchorelements to a second relative location, wherein the anchor elements ofeach pair of anchor elements are closer together than at the firstrelative location; and securing each pair of anchor elements together atthe second relative location on one side of the mitral valve leaflet.18. The method of claim 17, wherein translating each pair of anchorelements to the second relative location further comprises forming afold in the mitral valve leaflet, the fold being disposed between eachpair of anchor elements.
 19. The method of claim 17, wherein the mitralvalve leaflet is released from the distal end of the delivery catheterafter inserting each pair of anchor elements, and the distal end of thedelivery catheter is re-secured to the mitral valve leaflet beforeinserting each subsequent pair of anchor elements into the mitral valveleaflet.
 20. The method of claim 17, wherein the two or more pairs ofanchor elements are disposed within lumens of the delivery catheterother than the suction lumen prior to insertion into the mitral valveleaflet.